This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (345)  • Contact me when this article is cited  Related Content  • Related letter  • Related articles  • Similar articles in JAMA  Topic Collections  • Gastrointestinal Diseases  • Randomized Controlled Trial  • Alert me on articles by topic

Follow-up of a Randomized Controlled Trial

Stuart Jon Spechler, MD; Edward Lee, MD; Dennis Ahnen, MD; Raj K. Goyal, MD; Ikuo Hirano, MD; Francisco Ramirez, MD; Jean-Pierre Raufman, MD; Richard Sampliner, MD; Thomas Schnell, MD; Stephen Sontag, MD; Z. Reno Vlahcevic, MD; Renee Young, MD; William Williford, PhD

JAMA. 2001;285:2331-2338.

Context  Severe gastroesophageal reflux disease (GERD) is a lifelong problem that can be complicated by peptic esophageal stricture and adenocarcinoma of the esophagus.

Objective  To determine the long-term outcome of medical and surgical therapies for GERD.

Design and Setting  Follow-up study conducted from October 1997 through October 1999 of a prospective randomized trial of medical and surgical antireflux treatments in patients with complicated GERD. Mean (median) duration of follow-up was 10.6 years (7.3 years) for medical patients and 9.1 years (6.3 years) for surgical patients.

Participants  Two hundred thirty-nine (97%) of the original 247 study patients were found (79 were confirmed dead). Among the 160 survivors (157 men and 3 women; mean [SD] age, 67 [12] years), 129 (91 in the medical treatment group and 38 in the surgical treatment group) participated in the follow-up.

Main Outcome Measures  Use of antireflux medication, Gastroesophageal Reflux Disease Activity Index (GRACI) scores, grade of esophagitis, frequency of treatment of esophageal stricture, frequency of subsequent antireflux operations, 36-item Short Form health survey (SF-36) scores, satisfaction with antireflux therapy, survival, and incidence of esophageal adenocarcinoma, compared between the medical antireflux therapy group and the fundoplication surgery group. Information on cause of death was obtained from autopsy results, hospital records, and death certificates.

Results  Eighty-three (92%) of 90 medical patients and 23 (62%) of 37 surgical patients reported that they used antireflux medications regularly (P<.001). During a 1-week period after discontinuation of medication, mean (SD) GRACI symptom scores were significantly lower in the surgical treatment group (82.6 [17.5] vs 96.7 [21.4] in the medical treatment group; P = .003). However, no significant differences between the groups were found in grade of esophagitis, frequency of treatment of esophageal stricture and subsequent antireflux operations, SF-36 standardized physical and mental component scale scores, and overall satisfaction with antireflux therapy. Survival during a period of 140 months was decreased significantly in the surgical vs the medical treatment group (relative risk of death in the medical group, 1.57; 95% confidence interval, 1.01-2.46; P = .047), largely because of excess deaths from heart disease. Patients with Barrett esophagus at baseline developed esophageal adenocarcinomas at an annual rate of 0.4%, whereas these cancers developed in patients without Barrett esophagus at an annual rate of only 0.07%. There was no significant difference between groups in incidence of esophageal cancer.

Conclusion  This study suggests that antireflux surgery should not be advised with the expectation that patients with GERD will no longer need to take antisecretory medications or that the procedure will prevent esophageal cancer among those with GERD and Barrett esophagus.

Author Affiliations: Department of Veterans Affairs Medical Center, Dallas, Tex (Drs Spechler and Lee); Department of Veterans Affairs Medical Center, Denver, Colo (Dr Ahnen); Department of Veterans Affairs Medical Center, West Roxbury, Mass (Drs Goyal and Hirano); Department of Veterans Affairs Medical Center, Phoenix, Ariz (Dr Ramirez); Department of Veterans Affairs Medical Center, Little Rock, Ark (Dr Raufman); Department of Veterans Affairs Medical Center, Tucson, Ariz (Dr Sampliner); Department of Veterans Affairs Medical Center, Hines, Ill (Drs Schnell and Sontag); Department of Veterans Affairs Medical Center, Richmond, Va (Dr Vlahcevic); Department of Veterans Affairs Medical Center, Omaha, Neb (Dr Young); and Department of Veterans Affairs Medical Center, Perry Point, Md (Dr Williford). Dr Vlahcevic is deceased.

RELATED LETTER

Medical vs Surgical Treatment of Gastroesophageal Reflux
Albert M. Harary, Steven R. DeMeester, Ronald A. Hinder, Reginald V. N. Lord, Stefan Öberg, and Stuart Jon Spechler
JAMA. 2001;286(14):1709-1712.
EXTRACT | FULL TEXT  

RELATED ARTICLES

Surgical Therapy for Reflux Disease
Peter J. Kahrilas
JAMA. 2001;285(18):2376-2378.
EXTRACT | FULL TEXT  

May 9, 2001
JAMA. 2001;285(18):2393-2394.
EXTRACT | FULL TEXT  

Gastroesophageal Reflux Disease
JAMA. 2001;285(18):2408.
PDF  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Review: Barrett's esophagus and the increasing role of endoluminal therapy
Smith and Lightdale
Therapeutic Advances in Gastroenterology 2008;1:121-142.
ABSTRACT  

Comparing laparoscopic antireflux surgery with esomeprazole in the management of patients with chronic gastro-oesophageal reflux disease: a 3-year interim analysis of the LOTUS trial
Lundell et al.
Gut 2008;57:1207-1213.
ABSTRACT | FULL TEXT  

The Incidence of Esophageal Cancer and High-Grade Dysplasia in Barrett's Esophagus: A Systematic Review and Meta-Analysis
Yousef et al.
Am J Epidemiol 2008;168:237-249.
ABSTRACT | FULL TEXT  

Long-term results of redo gastro-esophageal reflux disease surgery
Avaro et al.
Eur. J. Cardiothorac. Surg. 2008;33:1091-1095.
ABSTRACT | FULL TEXT  

Measuring the Effectiveness of Laparoscopic Antireflux Surgery: Long-term Results
Gee et al.
Arch Surg 2008;143:482-487.
ABSTRACT | FULL TEXT  

Mechanisms of acid, weakly acidic and gas reflux after anti-reflux surgery
Bredenoord et al.
Gut 2008;57:161-166.
ABSTRACT | FULL TEXT  

The association of gastric leptin with oesophageal inflammation and metaplasia
Francois et al.
Gut 2008;57:16-24.
ABSTRACT | FULL TEXT  

Regional Variation in Surgery for Gastroesophageal Reflux Disease in Ontario
Lopushinsky et al.
SURG INNOV 2007;14:35-40.
ABSTRACT  

Ageing and the gut
D'Souza
Postgrad. Med. J. 2007;83:44-53.
ABSTRACT | FULL TEXT  

A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication Versus Proton Pump Inhibitors for Treatment of Patients With Chronic Gastroesophageal Reflux Disease: One-Year Follow-Up
Anvari et al.
SURG INNOV 2006;13:238-249.
ABSTRACT  

Nonacid reflux in patients with chronic cough on Acid-suppressive therapy.
Tutuian et al.
Chest 2006;130:386-391.
ABSTRACT | FULL TEXT  

Genetic Mechanisms of TP53 Loss of Heterozygosity in Barrett's Esophagus: Implications for Biomarker Validation.
Wongsurawat et al.
Cancer Epidemiol. Biomarkers Prev. 2006;15:509-516.
ABSTRACT | FULL TEXT  

Gastro-oesophageal reflux disease
Fox and Forgacs
BMJ 2006;332:88-93.
FULL TEXT  

Concepts in the Prevention of Adenocarcinoma of the Distal Esophagus and Proximal Stomach
Souza and Spechler
CA Cancer J Clin 2005;55:334-351.
ABSTRACT | FULL TEXT  

Citric Acid Cough Threshold in Patients With Gastroesophageal Reflux Disease Rises After Laparoscopic Fundoplication
Ziora et al.
Chest 2005;128:2458-2464.
ABSTRACT | FULL TEXT  

Outcomes of fundoplication: causes for concern, newer options
Hassall
Arch. Dis. Child. 2005;90:1047-1052.
ABSTRACT | FULL TEXT  

Long term failure of endoscopic gastroplication (EndoCinch)
Schiefke et al.
Gut 2005;54:752-758.
ABSTRACT | FULL TEXT  

What is the best management strategy for high grade dysplasia in Barrett's oesophagus? A cost effectiveness analysis
Shaheen et al.
Gut 2004;53:1736-1744.
ABSTRACT | FULL TEXT  

Gastroesophageal Reflux Disease, Barrett Esophagus, and Esophageal Adenocarcinoma
Chang and Katzka
Arch Intern Med 2004;164:1482-1488.
ABSTRACT | FULL TEXT  

Symptom evaluation in reflux disease: workshop background, processes, terminology, recommendations, and discussion outputs
Dent et al.
Gut 2004;53:iv1-iv24.
ABSTRACT | FULL TEXT  

Quality of life assessment in gastro-oesophageal reflux disease
Irvine
Gut 2004;53:iv35-iv39.
ABSTRACT | FULL TEXT  

Barrett's esophagus: the role of laparoscopic fundoplication
Abbas et al.
Ann. Thorac. Surg. 2004;77:393-396.
ABSTRACT | FULL TEXT  

Health Care Utilization After Medical and Surgical Therapy for Gastroesophageal Reflux Disease: A Population-Based Study, 1996 to 2000
Khaitan et al.
Arch Surg 2003;138:1356-1361.
ABSTRACT | FULL TEXT  

Minerva
BMJ 2003;327:E261-261.
FULL TEXT  

Symptoms Are a Poor Indicator of Reflux Status After Fundoplication for Gastroesophageal Reflux Disease: Role of Esophageal Functions Tests
Galvani et al.
Arch Surg 2003;138:514-519.
ABSTRACT | FULL TEXT  

Screening and Surveillance for Barrett Esophagus in High-Risk Groups: A Cost-Utility Analysis
Inadomi et al.
ANN INTERN MED 2003;138:176-186.
ABSTRACT | FULL TEXT  

A 59-Year-Old Woman With Gastroesophageal Reflux Disease and Barrett Esophagus
Spechler
JAMA 2003;289:466-475.
FULL TEXT  

Update in Gastroenterology
Greenberger
ANN INTERN MED 2003;138:45-53.
FULL TEXT  

Endocinch therapy for gastro-oesophageal reflux disease: a one year prospective follow up
Mahmood et al.
Gut 2003;52:34-39.
ABSTRACT | FULL TEXT  

Argon plasma coagulation therapy for ablation of Barrett's oesophagus
Deviere
Gut 2002;51:763-764.
FULL TEXT  

A rational approach to uninvestigated dyspepsia in primary care: review of the literature
Arents et al.
Postgrad. Med. J. 2002;78:707-716.
ABSTRACT | FULL TEXT  

Laparoscopic fundoplication is the treatment of choice for gastro-oesophageal reflux disease
Lundell
Gut 2002;51:468-471.
FULL TEXT  

Laparoscopic fundoplication is the treatment of choice for gastro-oesophageal reflux disease
Galmiche and Zerbib
Gut 2002;51:472-474.
FULL TEXT  

Postoperative Symptoms and Failure After Antireflux Surgery
Khajanchee et al.
Arch Surg 2002;137:1008-1014.
ABSTRACT | FULL TEXT  

Gastroesophageal Reflux, Barrett Esophagus, and Esophageal Cancer: Scientific Review
Shaheen and Ransohoff
JAMA 2002;287:1972-1981.
ABSTRACT | FULL TEXT  

Gastroesophageal Reflux, Barrett Esophagus, and Esophageal Cancer: Clinical Applications
Shaheen and Ransohoff
JAMA 2002;287:1982-1986.
ABSTRACT | FULL TEXT  

Late Outcomes After Laparoscopic Surgery for Gastroesophageal Reflux
Liu et al.
Arch Surg 2002;137:397-401.
ABSTRACT | FULL TEXT  

Barrett's Esophagus
Spechler
NEJM 2002;346:836-842.
FULL TEXT  

Results of Collis gastroplasty and selective fundoplication, using a left thoracoabdominal approach, for failed antireflux surgery
Legare et al.
Eur. J. Cardiothorac. Surg. 2002;21:534-540.
ABSTRACT | FULL TEXT  

Surgery relieved symptoms but decreased survival more than medical treatment in gastro-oesophageal reflux disease
Richter
Evid. Based Med. 2002;7:26-26.
FULL TEXT  

Medical vs Surgical Treatment of Gastroesophageal Reflux
Harary et al.
JAMA 2001;286:1709-1712.
FULL TEXT  

Surgery Is Not the Treatment of Choice for GERD
JWatch Gastroenterology 2001;2001:1-1.
FULL TEXT  

Surgery Is Less Beneficial for Severe GERD than We Thought
JWatch General 2001;2001:4-4.
FULL TEXT  

Surgical Therapy for Reflux Disease
Kahrilas
JAMA 2001;285:2376-2378.
FULL TEXT